| These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Amici Pharma Inc. | 20260519 | 2 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Jubilant Cadista Pharmaceuticals Inc. | Aavis Pharmaceuticals Inc. | 20260209 | 1 |
| These highlights do not include all the information needed to use ZORYVE cream safely and effectively. See full prescribing information for ZORYVE cream. ZORYVE ® (roflumilast) cream 0.3%, 0.15%, 0.05%, for topical use Initial U.S. Approval: 2011 | Arcutis Biotherapeutics, Inc. | DPT Laboratories, Ltd | 20260130 | 12 |
| These highlights do not include all the information needed to use ZORYVE foam, 0.3%, safely and effectively. See full prescribing information for ZORYVE foam, 0.3%. ZORYVE ® (roflumilast) topical foam, 0.3% Initial U.S. Approval: 2011 | Arcutis Biotherapeutics, Inc. | DPT Laboratories, Ltd | 20260130 | 6 |
| These highlights do not include all the information needed to use ROFLUMILAST tablets safely and effectively. See full prescribing information for ROFLUMILAST tablets. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Strides Pharma Science Limited | 20260109 | 8 |
| These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Major Pharmaceuticals | 20251210 | 5 |
| These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | MAJOR PHARMACEUTICALS | MSN Pharmaceuticals Inc. | 20251204 | 4 |
| These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Micro Labs Limited | 20250724 | 6 |
| These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Aurobindo Pharma Limited | 20250527 | 6 |
| ROFLUMILAST TABLETS. These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Golden State Medical Supply, Inc. | 20250321 | 1 |
| These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20250313 | 5 |
| These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | American Health Packaging | 20241121 | 2 |
| These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | MSN Pharmaceuticals Inc. | 20240827 | 3 |
| These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20240816 | 3 |
| These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Bryant Ranch Prepack | 20240815 | 100 |
| Roflumilast Tablets, for oral use | Zydus Lifesciences Limited | 20240812 | 4 |
| These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011 | Camber Pharmaceuticals, Inc. | Hetero Labs Limited Unit III | 20230428 | 2 |
| These highlights do not include all the information needed to use ROFLUMILAST safely and effectively. See full prescribing information for ROFLUMILAST. ROFLUMILAST (roflumilast) TABLET for ORAL use. Initial U.S. Approval: 2011 | Solco Healthcare US, LLC. | Prinston Pharmaceutical Inc. | Zhejiang Huahai Pharmaceutical Co., LTD | 20220510 | 1 |
| These highlights do not include all the information needed to use DALIRESP safely and effectively. See full prescribing information for DALIRESP. DALIRESP ® (roflumilast) tablets Initial U.S. Approval: 2011 | AstraZeneca Pharmaceuticals LP | 20200312 | 15 |